- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04783038
Determining The Impact Of Distance Reiki On Patient Reported QOL And Immunity Among Multiple Myeloma Patients
The Effect of Distance Reiki on Patient Reported Quality of Life, Correlated With Changes in Immune Repertoires Among Multiple Myeloma Patients: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Reiki is a popular complementary medicine modality sought after by patients. This non- intrusive Japanese based therapy centers on the guiding of energy through a Reiki practitioner to the patient which facilitates innate healing by modulation of energy fields. Reiki is formally classified as biofield therapy by the National Center for Complementary and Alternative Medicine (NCCAM).
Current research indicates that Reiki shows promise as a noninvasive healing tool for mind and body, particularly among patients with cancer. However, the data validating the effectiveness of Reiki integrated within a structured medical paradigm and the effect on cancer immunity remains unknown.
Given the clear demand for Reiki among cancer patients but skepticism within the medical community, this trial will aim to determine an objective patient reported quality of life (PRQoL) benefit by utilizing validated tools, in order to effectively implement Reiki into traditional medical practice.
Multiple myeloma patients are at high risk of serious illness from the COVID-19 virus during this pandemic, and so distance Reiki will be carried out via video conferencing platform.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- Patients with Multiple Myeloma with stable disease or currently in maintenance therapy
- English Speaking
- Computer and internet access with video conferencing availability
Exclusion Criteria:
- Evidence of disease relapse at the post-transplant follow up visit
- Patient not returning to Mayo Clinic Rochester for subsequent post-transplant follow up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Distance Reiki
Subjects will be scheduled for once a week session of distance Reiki for 4 weeks.
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Reiki therapy session performed remotely over a Zoom® video conferencing platform led by Reiki Practitioners who are also Health Care Providers at the Mayo Clinic, and have at least 6 months of experience in Reiki.
|
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Sham Comparator: Sham Reiki
Subjects will be scheduled for once a week session of Sham distance Reiki for 4 weeks.
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Session performed remotely over a Zoom® video conferencing platform led by a Health Care Provider employed at the Mayo Clinic, but will have no experience in Reiki and will not be a certified Reiki Practitioner.
|
|
No Intervention: Standard of Care
Subjects will not receive any Reiki treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in patient-reported quality of life
Time Frame: Baseline, approximately 5 weeks
|
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey.
PROMIS measures are scored on the T-score metric.
High scores mean more of the concept being measured (eg.
more Fatigue, more Physical Function)
|
Baseline, approximately 5 weeks
|
|
Change in patient-reported overall quality of life
Time Frame: Baseline, approximately 5 weeks
|
Measured using the single item Linear Analogue Self-Assessment (LASA) that uses a 10-point Likert scale, where 0=as bad as it can be and 10=as good as it can be
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Baseline, approximately 5 weeks
|
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Acceptability of Distance Reiki among multiple myeloma (MM) outpatients.
Time Frame: Approximately 5 weeks
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Measured by using the "Was it worth it" (WIWI) questionnaire which patients will complete upon study completion.
This is a 3 item questionnaire which assesses patient satisfaction.
Higher scores indicate greater acceptability of the Reiki intervention.
|
Approximately 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenotypic characterization of circulating immune cells
Time Frame: Baseline, approximately 5 weeks
|
Measured using mass cytometry by time of flight (CyTOF) to phenotypically characterize the immune cells in peripheral blood
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Baseline, approximately 5 weeks
|
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Assessment of T-cell receptor repertoire and T-cell clonal diversity
Time Frame: Baseline, approximately 5 weeks
|
Analyzed using multiplex polymerase chain reaction (PCR) RNA-sequencing to define T-cell antigen receptor (TCR) repertoire.
|
Baseline, approximately 5 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martha Lacy, MD, Mayo Clinic
- Principal Investigator: Joselle M. Cook, MBBS, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Hemic and Lymphatic Diseases
- Multiple Myeloma
Other Study ID Numbers
- 20-007168
- NCI-2021-13433 (Registry Identifier: CTRP (Clinical Trials Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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